483
Hubei Gedian Humanwell Pharmaceutical Co., Ltd.FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd.
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
This FDA Form 483 was issued to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. in Ezhou, China, an API and API intermediate manufacturer, following an inspection from May 9-13, 2016. The inspection revealed two observations related to inadequate calibration of equipment and failure to follow cleaning procedures for sampling rooms. These issues indicate deficiencies in quality control and adherence to standard operating procedures.
- Product Type
- Drugs
Open in Dashboard
ID · e4fc8729-c2f0-4646-9aab-a0a54de43b45